Head of Quality

Job Description

Job Title

Job Description

Effective Tuesday, January 4, 2022, all U.S.-based employees are required to be fully vaccinated against COVID as a condition of employment at Philips. Employees with a sincerely held religious belief and/or disability impacting their ability to obtain the COVID vaccine can request a reasonable accommodation.

If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request. You may contact 888-367-7223, option 5, for assistance.

Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.

But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique individuals, with two things in common: An unwavering sense of purpose and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most.

The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.

In this role, you have the opportunity to make life better

Lead and implement impactful change as the Head of Quality role within Philips, Hospital Respiratory Care.

As the incumbent of this Quality role within Philips, your challenge will be to guide and support the Hospital & Respiratory Care team and cross functional groups to always do the right thing. This involves being a confident advisor and technical expert on approvals, regulatory compliance and quality management related topics, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve.

You are responsible for:

• Manage, lead and implement strategic remediation efforts while effectively collaborating and driving cross functional teams and project owners.
• Formulate the medium-term policy for the Q&R area and processes results into a strategic plan.
• Overall control of planning, staffing, budgeting, managing expense priorities, and recommending and implementing changes to methods.
• Create and deploy Quality strategy for business management and quality systems to ensure consistent, standardized execution of Philips Excellence Process Framework processes.
• Oversee the Quality management representatives for all key regulatory agencies for product safety and quality (e.g: US FDA). Develop and maintain an effective working relationship with US FDA and other international regulatory bodies & competent authorities. Ensures that the organization’s products meet customer requirements and applicable quality standards.
• Ensure that all products to be released comply with all the relevant safety and environmental policies and regulations by implementing requirements, conditions and enablers in the Business.
• Participate with other senior managers to establish strategic plans and objectives. Makes final decisions on administrative or operational matters and ensures effective achievement of objectives.
• Participate in corporate development of methods, techniques and evaluation criteria for projects, programs, and people. Ensures budgets and schedules meet corporate requirements.
• Develop territory plans and participates in strategic and tactical planning. Regularly interact with executives and/or major customers.

You are part of

The Connected Care (CC) Business is a global health technology leader in Hospital Patient Monitoring, Emergency Care, Sleep and Respiratory Care, EMR & Care Management, Ambulatory Patient Monitoring and Clinical Data Services. By advancing connected care, we seamlessly connect patients and caregivers across care settings, delivering clinical, operational and therapeutic solutions that improve health outcomes, patient and staff experience and lower costs.

To succeed in this role, you’ll need a customer-first attitude and the following

• Bachelor’s degree required in science or engineering fields. Master’s preferred.
• Strong management skills in a challenging working environment with a proven track record of 10+ years of experience in managing and transforming a large team
• Expert knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, and ISO 9001.
• Demonstrated 483, Warning Letter, and Consent Decree Remediation Leadership.
• Strong leadership skills and demonstrated ability to influence change and challenge status quo with respect to opportunities for improvement
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills
• Advanced problem-solving, organizational, analytical and critical thinking skills
• Ability to manage competing priorities in a fast-paced environment
• Ability to serve as best practice/quality resource within own discipline or as technical expert on functional or cross-functional teams or projects
• Proven ability to lead cross-functional, diverse teams with competing goals

In return, we offer you

At Philips, we are driven by our mission to improve the lives of 2 billion people per year by 2025, and every day we move closer to achieving our goal by creating cutting-edge solutions that lead to confident diagnosis, improved care, and increased quality of life for patients. If you are interested in driving action to improve patients’ lives so they get home healthier and faster and stay there longer, then this position is poised to help you achieve that goal.

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

Our benefits can be found here: https://www.careers.philips.com/na/en/total-rewards-at-philips.

How we work at Philips

Our newly adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart – which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home – for our hybrid roles.

Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.

Our hybrid working model is defined in 3 ways:

We believe in the importance of impactful collaboration: There's a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving.

We embrace flexibility: Choosing where, when, and how to work can vary according to task and team schedules. Flexibility isn’t office or online, it means choosing the space that works best for you, your teams, and our customers on a case-by-case basis.

We want to be at our best: The way we work, and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.

Why should you join Philips?

Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.

Visit our careers website to explore what it’s like working at Philips, read stories from our employee blog, find information about our recruitment process and answers to some frequently asked questions.

It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.

As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.

Equal Employment and Opportunity Employer/Disabled/Veteran

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